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Not yet recruitingNCT07882420IMADESUpdated Oct 20, 2026

Role of Artificial Intelligence in Breast Cancer Screening Via Mammography

An interventional study of Transpara software in Breast Cancer, sponsored by Centre Antoine Lacassagne. Not yet recruiting at 2 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Centre Antoine Lacassagne · Not applicable, Interventional, and Screening

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,222
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

to evaluate the diagnostic performance of radiologists using the Transpara™ Incepto® software to interpret 2D mammograms with tomosynthesis as part of breast cancer screening

02

Conditions studied

  • Breast Cancer

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Keywords

  • screening
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 1,222 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

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Lead sponsor

Centre Antoine Lacassagne is the lead sponsor of 66 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A woman referred for a bilateral mammogram as part of individual or organised screening,
  • Patient aged 18 or over,
  • A patient who has read the information leaflet and signed the informed consent form,
  • A patient with health insurance cover.

Exclusion criteria

Exclusion Criteria:

  • Patients with a history of breast cancer,
  • Patients with a history of breast surgery (cosmetic and/or therapeutic),
  • Patients with a history of radiotherapy to the breast,
  • Vulnerable populations and participants as defined in Articles 64 to 68 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,222 participants (estimated)

Study arms

  • Experimental
    global arm

    use of artificial intelligence software for breast cancer screening

    Device: Transpara software

Interventions

  • DeviceTranspara software

    use of transpara software for breast cancer screening

06

What researchers measure

Primary outcomes

  1. Sensitivity and specificity (diagnostic performance) of radiologist using the Transpara software

    Medical conclusion of radiologist using the Transpara software at baseline compared to radiologist's decision alone at 2 years, or the result of the biopsy (positive during the follow-up period or negative at 2 years).

    Time frame: 2 years

Secondary outcomes

  1. Rate of change in care following the use of the software Transpara by radiologist compared to the decision taken before by the radiologist alone

    Rate of change in care following the use of the software Transpara by radiologist compared to the decision taken before by the radiologist alone

    Time frame: Baseline

  2. Diagnostic performance of radiologist alone and radiologist using the Transpara software

    Compare the diagnostic performance of the radiologist working alone and the radiologist using the software at baseline

    Time frame: Baseline

  3. Radiologist evaluation false-positive rate obtained by radiologist using the Transpara software

    To assess the false-positive rate generated by the radiologist using the Transpara™ Incepto software

    Time frame: Baseline

  4. Adverses events assessed by CTCAE 6.0

    To assess adverse events associated with additional diagnostic investigations prompted by the use of the Transpara™ Incepto® software.

    Time frame: 2 years

  5. comparaison of diagnosis performance of radiologist alone and radiologist using the Transpara software

    To compare the diagnostic performance of the Transpara™ Incepto® software with that of the radiologist alone.

    Time frame: 2 years

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07882420
Lead sponsor
Centre Antoine Lacassagne
Responsible party
Sponsor
First posted
Oct 20, 2026
Start date
Jan 31, 2027 (estimated)
Primary completion
Mar 31, 2031 (estimated)
Completion
Sep 30, 2032 (estimated)
Last update
Oct 20, 2026

Study contacts

Frédérique JACQUINOT
Contact
drci-promotion@nice.unicancer.fr
04 92 03 10 24 ext. +33
Laura ELKIND, doctor
principal investigator · Centre Antoine Lacassagne

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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